Agency IQ

OCTOBER 27, 2023

Upcoming Webinar Hosted by Xtalks Webinar/Seminar ( OPEN) Xtalks 11/6/2023 11/6/2023 What is the evidence for high-risk medical devices in the field of cardiovascular disease and diabetes?

Regulations 40

Regulations Pharmaceuticals Production Packaging 40

Agency IQ

MAY 31, 2024

Even small changes in the Parliament’s composition could have an impact on ongoing legislative discussions, such as the revisions to the pharma reform package. The current European Parliament and Commission have confirmed their position on the pharma package, but the European Council is still working on its negotiation position.

Regulations 40

Regulations Production Compliance Pharmaceuticals 40

Agency IQ

MAY 3, 2024

The pharma reform package remains in E.U. In the interim, the European Council will continue to discuss the package, and stakeholders may gain some insight into the Council’s thinking near the end of May. Start Date End Date Event Event Type Organization 4/30/2024 4/30/2024 Seminar No. On April 10, the E.U.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

Agency IQ

AUGUST 2, 2024

Another legislative area that will also likely receive more attention will be the pharma reform package , since the two Parliament rapporteurs to lead the package negotiations were recently appointed.

Regulations 40

Regulations Clinical Trials Production Trials 40

Drug Target Review

DECEMBER 5, 2024

2 However, utilisation of biological systems introduces variability and by-products, as well as a challenge unique to AAV production: the assembly of full capsids with correctly packaged DNA, partially filled capsids containing partial vector and/or host cell DNA, and empty capsids.

Therapies 52

Therapies Virus DNA Compliance 52

Agency IQ

OCTOBER 6, 2023

AgencyIQ compiled these data using information in approval letters and review packages posted to the Drugs@FDA database. While the definition of NME has changed over the years, it can sometimes include a combination product consisting of at least one drug that has previously been approved. What’s next? Stay tuned.

FDA 52

FDA Biosimilars Science Drugs 52

The Pharma Data

MAY 14, 2021

Never before have they been available to the public all together, in one special “master package” such as what you’re about to get your hands on here and now. Until now, he’s only “released” some of these secrets in dribs-and-drabs to some of his more trusted students. Anyway, I could go on and on.

Packaging 52

Packaging Production Vaccine International 52